JUDGMENT OF 15. 3. 1983 — CASE 145/82 COMMISSION v ITALY

In Case 145/82

THE COURT composed of: P. Pescatore, President of the Second Chamber, acting as President, A. O'Keeffe and U. Everling (Presidents of Chambers), G. Bosco, T. Koopmans, O. Due and K. Bahlmann, Judges, Advocate General: G. Reischl Registrar: P. Heim

gives the following

JUDGMENT

Facts and Issues

The facts of the case, the course of the procedure and the conclusions, submissions and arguments of the parties may be summarized as follows:

I — Facts and written procedure

1. The purpose of Council Directives No 65/65/EEC of 26 January 1965 (Official Journal, English Special Edition 1965-1966, p. 20), No 75/318/EEC of 20 May 1975 (Official Journal 1975, L 147, p. 1) and No 75/319/EEC of 20 May 1975 (Official Journal 1975, L 147, p. 13) is to approximate provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. In Articles 22, 3 and 38 respectively the directives stipulate that the Member States must within 18 months of their notification bring into force the measures needed to comply with them. That period expired on 31 December 1966 for Directive No 65/65, as amended by Council Directive No 66/454 of 28 July 1966 (Official Journal, English. Special Edition 1965-1966, p. 168), and on 22 November 1976 for the other two. By a letter of 23 September 1977 the Permanent Representation of Italy sent the Commission a copy of a draft law prepared by the Italian Ministry of Health concerning the implementation of Directives Nos 65/65, 75/318 and 75/319. After studying that draft the Commission, by letter of 31 May 1978, drew the attention of the Italian Government to the fact that the directives of 20 May 1975 as well as all the provisions of the directive of 26 January 1965 ought to have been implemented in the national legal system by 22 November 1976. In reply the Permanent Representation of Italy informed the Commission in a telex message of 11 July 1978 that the draft in question was before the Senate for scrutiny and that the Italian authorities were endeavouring to have it passed with all due speed. Then, by letter of 7 December 1978, the Permanent Representation informed the Commission that the draft law to implement the directives had been approved by the Senate and that the Italian Government was hopeful that it would complete the parliamentary adoption procedure in a very short while. When it received no word that the draft law had been finally passed the Commission sent the Italian Republic a letter on 9 April 1980 giving it notice that it considered that the Italian Republic had failed to fulfil its obligations under the directives and requesting it, in accordance with Article 169 of the EEC Treaty, to submit its observations within two months. By a letter dated 17 June 1980 the Italian Government informed the Commission that it had not been possible for the parliamentary procedure to adopt the bill, which had already been approved by the Senate, to be completed owing to the premature dissolution of the Chambers, that the Minister of Health had consequently decided to review the draft, to bring it up to date and to supplement it and that this was now virtually done. Whilst acknowledging that it was expedient to introduce new rules on proprietary medicinal products the Italian Government pointed out that by and large it was already complying with the directives in question by means inter alia of ministerial circulars. On 25 November 1981 the Commission, finding that the rules notified to it had still not been adopted and considering that administrative practices could not constitute a sufficient means of performing the obligation imposed on Member States under Article 189 of the EEC Treaty as addressees of directives, delivered the reasoned opinion provided for by Article 169 of the Treaty requesting the Italian Government to comply with it within two months. By a letter of 2 March 1982 the Italian Government informed the Commission that it intended to make every effort to expediate the implementation of 45 directives the dates for the implementation of which had expired and which included the three directives in question, but that it was unable to commit itself to a precise date.

2. Having received no further word from the Italian Government the Commission, acting pursuant to the second paragraph of Article 169 of the Treaty, referred to the Court the alleged failure of the Italian Republic to fulfil its obligations under Article 189 of the Treaty.

3. The Commission's application was registered at the Court on 11 March 1982. The written procedure followed the normal course apart from the fact that there was no rejoinder. Upon hearing the repon of the Judge-Rapporteur and the views of the Advocate General, the Court decided to open the oral procedure without any preparatory inquiry.

II — Conclusions of the parties

The Commission claims that the Court should:

1) Declare that, by failing to implement within the prescribed period the provisions needed to comply with Council Directives Nos 65/65/EEC of 26 January 1965, 75/318/EEC of 20 May 1975 and 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating, to proprietary medicinal products, the Italian Republic has failed to fulfil its obligations under the Treaty;

2) Order the defendant to pay the costs.

The Italian Republic contends that the Court should dismiss the application.

III — Submissions and arguments of the parties

The Commission of the European Communities, the applicant, relies on the third paragraph of Article 189 of the Treaty which states that directives are to be binding, as to the result to be achieved, upon each Member State to which they are addressed. It stresses that the fact that directives are binding means that Member States must observe the time-limits which they lay down for the adoption of the provisions of domestic law needed to implement them. The Commission states that' the Italian Republic has still not passed the draft law needed to implement the directives in question.

Referring to the reasons set out in the reasoned opinion of 25 November 1981 the Commission contends that the ministerial circulars on which the Italian Government relies are not capable of guaranteeing compliance with Article 189 of the Treaty because they may be altered at the whim of the relevant ministry and lack the appropriate publicity. Hitherto the sphere of proprietary medicinal products has been governed by statute. That is why the directives in issue are meant to be converted into provisions of domestic law having the same legal force as those which apply to the sphere of proprietary medicinal products in the Member State in question.

The Commission then goes on to point out that the provisions notified in the appendix to the Italian Government's letter of 17 June 1980 do not appear to take any account of Article 7 and 10 of Directive No 65/65 or of Articles 16 (2), and (3), 20 and 22 of Directive No 75/319.

The Commission therefore considers that the Italian Republic has failed to adopt within the prescribed periods the measures needed to implement the directives in question.

The Government of the Italian Republic, the defendant, regrets the Commission's refusal to take into consideration the administrative provisions already adopted by the competent ministry.

It points out that the Commission's objection is not that the provisions adopted are not capable of putting the directives into effect in domestic law. In its view the Commission is thus ignoring the prerogative of a Member State under the third paragraph of Article 189 of the Treaty freely to choose the means which it considers to be the most suitable for incorporating directives into its domestic legal order. The defendant contends that in its application the Commission undertakes a review which goes beyond the limits of assessing the suitability of the measures taken by a Member State for the adoption of the required provisions.

The Italian Government also disputes the existence of a rule, expressed in general terms by the Commission, to the effect that directives must be adopted by a statute if the subject-matter is governed by statute in domestic law. Such an obligation would constitute in substance the abolition of the right of Member States to make use in addition of regulations and administrative provisions.

The Italian Government then goes on to contend that the Commission bases its application on the unwarrantable assumption that ministerial circulars are mere administrative practices. It observes that circulars are genuine binding administrative provisions. For that reason it considers that the Commission failed in its duty to consider the action already taken to incorporate the directives in question in national law.

In its reply the Commission states that the Italian Government has itself admitted several times, in particular in the ministerial report on the 1977 draft law, that it has not entirely complied with the directives in issue, thus confirming that the application is well founded.

The Commission next denies having made the unwarrantable assumption that the ministerial circulars on which the Italian Government relies are mere administrative practices. The Commission observes that it had already separately examined both categories in its reasoned opinion of 25 November 1981. When doing so it noticed that there was no provision at all in Italian law (statute or circular) corresponding to Articles 7 or 10 of Directive No 65/65.

The Commission also denies that it refused from the outset to take into consideration the ministerial circulars of which the texts were notified in the appendix to the Italian Government's letter of 17 June 1980. However, for ministerial circulars to be capable of constituting a suitable means of implementing Community directives, in the Commission's opinion the two fundamental requirements as to uniformity of rules and certainty in legal situations must also be fulfilled.

The Commission bases that view on the case-law of the Court as contained, in particular, in the judgment of 6 May 1980 in Case 102/79 Commission v Belgium [1980] ECR 1473. In that case the Court stated that harmonizing directives are meant to be converted into provisions of domestic law which have the same legal force as those which apply in the Member States to the subject-matter governed by the directive (principle of uniformity of rules) and, secondly, that the Member States must implement the directives in a way which fully meets the requirements of clarity and certainty in legal situations sought by the directives (principle of certainty in legal situations).

When it studied the circulars sent by the Italian Government the Commission realized that they did not satisfy either of those two requirements. In the first place, since proprietary medicinal products are governed by statutory provisions in Italy, to implement the directives in issue by means of ministerial circulars would not satisfy the requirement of uniformity of rules. Secondly, the ministerial circulars are internal administrative instructions which are not officially published in any form and may be altered at any time.

In the Commission's view those findings lead to the conclusion that the Italian Republic has failed to fulfil its obligations under the third paragraph of Article 189 of the Treaty.

IV — Oral procedure

The parties presented oral argument at the sitting on 7 December 1982.

The Italian Government produced the ministerial order of 18 December 1979 laying down a procedure for the general review of proprietary medicinal products and also a number of circulars issued by the Ministry of Public Health.

The Advocate General delivered his Opinion at the sitting on 2 February 1983.

Decision

1. By application lodged at the Court Registry on 11 May 1982 the Commission of the European Communities brought an action before the Court under Article 169 of the EEC Treaty for a declaration that by failing to adopt within the prescribed periods the provisions needed to comply with Council Directives Nos 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, the Italian Republic has failed to fulfil its obligations under Article 189 of the EEC Treaty.

2. The purpose of Council Directive No 65/65. of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (Official Journal, English Special Edition 1965-1966, p. 20) is to eliminate the disparities in this sector liable to have the greatest effect on the functioning of the common market. To that end it lays down provisions on authorization to place proprietary medicinal products on the market, the suspension and revocation of such authorization and on the labelling of proprietary medicinal products.

3. Council Directive No 75/318 of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (Official Journal 1975, L 147, p. 1) continues the approximation initiated by Directive No 65/65 by laying down uniform rules for carrying out tests and trials, compiling dossiers and examining applications for marketing authorization. Those uniform rules are set out in a detailed annex to the directive, Article 2 of which requires Member States to take all appropriate measures to ensure that the competent authorities examine the particulars and documents submitted in support of applications for marketing authorization in accordance with the criteria laid down in that annex.

4. Council Directive No 75/319 of 20 May 1975, the second directive on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (Official Journal 1975, L 147, p. 13) concerns in particular the procedures to be followed by the competent authorities of the Member States when examining applications for marketing authorization. To assist in the adoption of a common attitude in this regard the directive sets up a Committee for Proprietary Medicinal Products consisting of representatives of the Member States and of the Commission.

5. The periods within which the Member States were to bring into force the provisions needed to comply with the three directives expired on 31 December 1966 for Directive No 65/65 and on 22 November 1976 for Directives Nos 75/318 and 75/319.

6. It is common ground that in Italy a draft law implementing the three directives and approved by the Senate in 1978 was -unable to complete the parliamentary procedure owing to the premature dissolution of the Chambers. The Italian Government maintains that the drawing up of a new draft law requires time as it is necessary to bring it up to date as regards its technical aspects.

7. The Italian Government contends, however, that the directives in question have by and large been implemented by administrative provisions. It refers in this regard to the Ministerial Order of 18 December 1979 laying down a procedure for the general review of proprietary medicinal products (Gazzetta Ufficiale della Repubblica Italiana No 351 of 28 December 1979) and to a number of circulars issued by the Ministry of Public Health, copies of which it has provided for the Court.

8. Although the recitals in the preamble to the ministerial order of 1979 evince the intention of the Italian authorities to adapt the procedure for granting marketing authorization to the requirements of the three directives, that fact is not sufficient to remedy the alleged failure. First, the ministerial order was adopted after the period prescribed for the implementation of the directives had expired. Secondly, the order is concerned only with the continued registration of proprietary medicinal products already registered before 1 January 1975.

9. As to the circulars relied upon by the Italian Government, they cover the procedure to be followed for authorizing the marketing of proprietary medicinal products. They do not govern either the suspension or revocation of such authorizations, the labelling of proprietary medicinal products or the rules applying to products imported from nonmember countries.

10. It should be added in this respect that, as the Court has already stressed on other occasions, in particular in its judgment of 6 May 1980 in Case 102/79 Commission v Belgium [1980] ECR 1473, mere administrative practices, which by their nature may be altered at the whim of the authorities and lack the appropriate publicity cannot be regarded as a valid fulfilment of the obligation imposed by Article 189 of the Treaty on Member States to which the directives are addressed.

11. It follows from all the considerations set out above that the Italian Government's argument to the effect that it is a matter for the Member States to which a directive is addressed to determine the methods to implement the directive is, though correct, nevertheless irrelevant in the present case. Indeed, apart from the fact that it was based at least in part on mere administrative practice, the implementation of the three directives in issue upon which the Italian Government relies, came too late and was incomplete.

12. In these circumstances it must therefore be declared that by failing to adopt within the prescribed periods the provisions needed to ensure the implementation of Council Directives Nos 65/65/EEC, 75/318/EEC and 75/319/EEC, the Italian Republic has failed to fulfil its obligations under Article 189 of the Treaty.

Costs

13. Under Article 69 (2) of the Rules of Procedure the unsuccessful party is to be ordered to pay the costs if they have been asked for in the successful party's pleading. Since the defendant has failed in its submissions, it must be ordered to pay the costs.

On those grounds, THE COURT hereby:

1 Declares that, by failing to adopt within the prescribed periods the provisions needed to ensure the implementation of Council Directives Nos 65/65/EEC of 26 January 1965 and 75/318/EEC and 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, the Italian Republic has failed to fulfil its obligations under Article 189 of the Treaty;

2 Orders the defendant to pay the costs.